FDA

The “logbook” during the FDA inspection at the pharmaceutical industries

It is here reported the text of  a FDA 2006 ”warning letter”  (from the FDA “Documentation and Standard Operating Procedures for cleaning” document)  in which is clearly presented the “poor record keeping” of a pharmaceutical industry.

“Laboratory records did not always include a description and identification of the sample received for testing, the date the sample was taken, the date the sample was received for testing and the data derived from the testing. 

There was no record that the laboratory received personnel monitoring sample of one person for the redacted fills. There was no record of analysis, yet the results were reviewed as acceptable. We are concerned about the failure to effectively review records at your facility.

In addition, analyst in the redacted Microbiology Laboratory do not enter the date on which the results are read into the logbook. Your proposed corrective action appears acceptable, but again there were several logbook record keeping deficiencies noted on the previous FDA 483 document”.